Multiple Sclerosis, Relapsing-RemittingCOGNIT-MSNCT05510817
Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS
A study testing Multiparametric assessment in people with Multiple Sclerosis, Relapsing-Remitting, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial summary
This prospective study combining non conventional MRI techniques, neuropsychological screening tools, and a neurophysiological work-up using a sensitive and validated battery, will evaluate the predictive value of these measures and will explore the changes of the cognitive scores from baseline. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Multiparametric assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Jun 2022to 6 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- active MS, according to the Lublin criteria
- disease duration < 10 years before initiating or changing a disease-modifying therapies,
- relapse- and steroid-free for at least 1 month before MRI acquisition
- between 18-50 years old
- having given informed consent
- with no significant comorbidity other than MS or substance abuse that could interfere with cognitive performances
Who cannot join
- progressive forms of MS
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU UCL Namur site Godinne
Yvoir, Namur
Frédéric London, MD, +3281423345, frederic.london@chuuclnamur.uclouvain.be
About this study
Official title: Multiparametric Clinical, Radiological, Neuropsychological, and Neurophysiological Assessment to Investigate Prognostic Factors for Disease Evolution and Treatment Response in MS: a Prospective Study.
This prospective study combining non conventional MRI techniques, neuropsychological screening tools, and a neurophysiological work-up using a sensitive and validated battery, will evaluate the predictive value of these measures and will explore the changes of the cognitive scores from baseline.
Read the detailed description
Neurologists are in need for reliable and robust predictive factors enabling to predict disease evolution and treatment response. Moreover, recent studies suggested that the evolution patterns of cognitive status in MS could be mixed, contradicting the concept that cognitive impairment in MS will inevitably increase over time.
The main aim of this prospective study is to investigate the predictors of disease evolution, as measured by the EDSS score, using a multiparametric assessment combining neuropsychological tests (BCcogSEP battery), MRI-derived metrics (volumetric brain parameters, tractography, diffusion tensor imaging and fiber tracking), patient-reported outcome measures, and neurophysiological tools (multimodal evoked potentials), and to explore the evolutionary patterns of cognitive status (changes from baseline).
The investigators planned to include 50 patients with active RRMS and initiating a new disease-modifying treatment.
Yearly assessment starting from study inclusion will be performed.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Multiparametric assessment
- Keywords
- MRI, evoked potentials, cognitive function, PROMs
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric assessmentOther
neuropsychological assessment, PRO measures, non-conventional MRI metrics
| Study group | Role | What they receive |
|---|---|---|
| RRMS patients | Other | RRMS patients initiating a new DMT Receives: Other: Multiparametric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of disease evolution
EDSS score worsening from baseline
Measured: 3 years
evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline
changes from baseline in cognitive scores
Measured: 3 years
baseline predictors of future cognitive impairment
abnormal cognitive performances based on cognitive scores (using BCcogSEP battery)
Measured: 3 years
Secondary outcomes (2)
alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment
fractional anisotropy
Measured: 3 years
predictive role of mEPS in predicting future disability
the Global Evoked Potential (GEP) score at study entry (baseline); EDSS score changes from baseline
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start6 Jun 2022
- Primary completion6 Jun 2026 (estimated)
- Study completion6 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Collaborators
- Saint-Luc University Hospital
- Responsible party
- Principal investigator, Frédéric London, University Hospital of Mont-Godinne
- Investigators
- Frédéric London, MD, Principal investigator, University Hospital Mont-Godinne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510817
- Sponsor's protocol ID
- B039202042775
- Acronym
- COGNIT-MS
- Status last verified
- Dec 2023
- First submitted
- 17 Aug 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Clinical, Radiological, Neuropsychological, and Neurophysiological Assessment to Investigate Prognostic Factors for Disease Evolution and Treatment Response in MS: a Prospective Study.
- ClinicalTrials.gov ID
- NCT05510817
- Acronym / sponsor ID
- COGNIT-MS / B039202042775
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- MRI, evoked potentials, cognitive function, PROMs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Collaborators
- Saint-Luc University Hospital
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 6 Jun 2026 (estimated)
- Study completion
- 6 Jun 2026 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study combining non conventional MRI techniques, neuropsychological screening tools, and a neurophysiological work-up using a sensitive and validated battery, will evaluate the predictive value of these measures and will explore the changes of the cognitive scores from baseline.
Detailed description
Neurologists are in need for reliable and robust predictive factors enabling to predict disease evolution and treatment response. Moreover, recent studies suggested that the evolution patterns of cognitive status in MS could be mixed, contradicting the concept that cognitive impairment in MS will inevitably increase over time.
The main aim of this prospective study is to investigate the predictors of disease evolution, as measured by the EDSS score, using a multiparametric assessment combining neuropsychological tests (BCcogSEP battery), MRI-derived metrics (volumetric brain parameters, tractography, diffusion tensor imaging and fiber tracking), patient-reported outcome measures, and neurophysiological tools (multimodal evoked potentials), and to explore the evolutionary patterns of cognitive status (changes from baseline).
The investigators planned to include 50 patients with active RRMS and initiating a new disease-modifying treatment.
Yearly assessment starting from study inclusion will be performed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RRMS patients | Other | Other: Multiparametric assessmentRRMS patients initiating a new DMT |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- active MS, according to the Lublin criteria
- disease duration < 10 years before initiating or changing a disease-modifying therapies,
- relapse- and steroid-free for at least 1 month before MRI acquisition
- between 18-50 years old
- having given informed consent
Key exclusion criteria (1 listed)
- progressive forms of MS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric assessmentneuropsychological assessment, PRO measures, non-conventional MRI metrics | Other | RRMS patients |
Primary outcome
Predictors of disease evolution
Time frame: 3 years
EDSS score worsening from baseline
evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline
Time frame: 3 years
changes from baseline in cognitive scores
baseline predictors of future cognitive impairment
Time frame: 3 years
abnormal cognitive performances based on cognitive scores (using BCcogSEP battery)
2 secondary outcomes
alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment
Time frame: 3 years
predictive role of mEPS in predicting future disability
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric London, MD principal investigator
University Hospital Mont-Godinne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiparametric assessment in people with Multiple Sclerosis, Relapsing-Remitting, run by University Hospital of Mont-Godinne at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frédéric London, MD (+3282413345, frederic.london@chuuclnamur.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors of disease evolution (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.